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Building the eCTD: Practical Solutions to Compile Electronic Submissions

  April 01, 2010  
Ramada Plaza Basel , Basel, Switzerland
Sep 23 2010 8:00AM - Sep 24 2010 5:30PM

This course will offer insight into the compilation of the eCTD, share experience and best practise gained during eCTD submissions in the EU, and the eCTD review process. The focus will be on practical experience gained in preparing and submitting electronically.

Key Topics:
  • Overview of eCTD readiness at the agencies
  • Impact of the eCTD on regulatory processes and procedures
  • Practical experience of submitting an eCTD in the EU
  • eCTD compilation and life cycle
  • Document granularity and readiness
  • Regulatory strategy facing technical issues
  • Specifications and standards versus regions and procedures
  • NeeS and its role in eSubmission

Event Code:

Organized by: DIA Europe
Invited Speakers: call contact
Deadline for Abstracts: call contact
Registration: DIA Europe TEL.: +41 61 225 51 51FAX:  +41 61 225 51 52
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